SuccessBeyondScience

GMP Manufacturing: Delivering quality on an accelerated schedule

The complex coordination of fast-track clinical supplies

Beyond the production line: Flexibility and rapid response

Coordinating the sourcing, setup and technology transfer of API and drug product in order to supply clinical sites with manufactured product is a complex series of steps involving multiple processes and stakeholders. Before any action can take place, it’s critical to properly familiarize each team with the characteristics of the compound and supply batch records and data from previous analyses.

In the case study described here, the complexity was multiplied by the requirement to simultaneously provide two unique drug substances and four drug product lots. Furthermore, Avista Pharma was challenged to complete the work on an accelerated schedule to meet tight timelines.

Before technology and materials transfer could begin, it was critical to set up coordination teams at multiple locations. Equipment trains were assessed for suitability, and utilization of a flexible drug product suite was developed. The API batch size was recalculated for optimal speed in processing.

Efficiencies were incorporated to minimize duplication, such as creating a plan for sample shipment to other sites, eliminating the transfer of analytical methods. At the same time, inefficiencies were avoided: When the existing MET lab was unable to meet the time requirements, work was re-routed to Avista Pharma’s microbiology facility. In addition, the team initiated ad-hoc formulation development, including qualification of new equipment and additional analytical method development, to address an issue of unexpectedly low clinical dose in one of the products.

Success in manufacturing is not only measured by the quantity of drug product produced. As in this case, the manufacturing stage requires coordinated activities across multiple locations with moving timelines. Avista Pharma’s success is grounded in quality processes, and bolstered by flexibility to meet clients’ changing demands. Whether it’s timing changes based on clinical trial requirements or modified batch quantities for different programs, we deliver quality products and results.

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